Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 3:38 PM
Study NCT ID:
NCT05121532
Status:
UNKNOWN
Last Update Posted:
2021-11-16
First Post:
2021-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-24', 'releaseDate': '2024-12-11'}], 'estimatedResultsFirstSubmitDate': '2024-12-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-11-14', 'studyFirstSubmitQcDate': '2021-11-14', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Serum Interleukin-15 and Interleukin-22 Levels', 'timeFrame': '3 months', 'description': '3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate\n\n1. Serum IL15 level .\n2. Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate\n\n1\\. Serum IL15 level . 2. Serum IL22 level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy', 'detailedDescription': 'This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.\n\nThis study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients suffering from non segmental vitiligo.\n\n * Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.\n\nExclusion Criteria:\n\n* • Patients with systemic or cutaneous inflammatory disorders.\n\n * Patients on treatment for vitiligo in last 3 months.\n * Pregnant and lactating patients.\n * Patients with history of diabetes.\n * Patients with history of autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT05121532', 'briefTitle': 'Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo', 'orgStudyIdInfo': {'id': 'Soh-Med-21-11-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non segmental vitiligo', 'description': 'serum analysis', 'interventionNames': ['Diagnostic Test: Interleukin-15 and Interleukin-22']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal volunteer', 'description': 'serum analysis', 'interventionNames': ['Diagnostic Test: Interleukin-15 and Interleukin-22']}], 'interventions': [{'name': 'Interleukin-15 and Interleukin-22', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo', 'armGroupLabels': ['non segmental vitiligo', 'normal volunteer']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at dermatology department balina central hospital', 'investigatorFullName': 'Samah Saeed Badrous', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-11', 'type': 'RELEASE'}, {'date': '2025-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Samah Saeed Badrous, resident doctor at dermatology department balina central hospital, Sohag University'}}}}